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Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 8 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 8 weeks for 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients receive irinotecan, leucovorin calcium, and fluorouracil as in group 1, arm I for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in group 1, arm II for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients receive leucovorin calcium and fluorouracil as in group 1, arm III for 1 course. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III. Treatment continues in the absence of disease progression or unacceptable toxicity.

Radiotherapy

Leucovorin Calcium

Al Benson

This randomized phase III trial is comparing the effectiveness of three adjuvant combination chemotherapy regimens in treating patients who are receiving radiation therapy and fluorouracil either before or after surgery for stage II or stage III rectal cancer. Drugs used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which adjuvant combination chemotherapy regimen is more effective in treating patients who are receiving radiation therapy and fluorouracil either before or after surgery for rectal cancer.

PRIMARY OBJECTIVES:

I. To compare the overall survival of patients treated with irinotecan, 5-FU and leucovorin versus those treated with oxaliplatin, leucovorin and 5-FU versus those treated with leucovorin and 5-FU for patients with stage II and III rectal cancer.

SECONDARY OBJECTIVES:

I. To determine sphincter preservation, tolerance of treatment and patterns of failure.

II. To describe patterns of failures

OTHER PRE-SPECIFIED OBJECTIVES:

I.To prospectively assess rectal function using the Patient Bowel Function/Uniscale questionnaire and the FACT Diarrhea Subscale in patients treated with an adjuvant program of pelvic radiation therapy and chemotherapy.

II. To correlate expression of key targets for 5-FU, leucovorin, oxaliplatin and irinotecan from tumor tissue biopsies with treatment efficacy III. To correlate tumor molecular prognostic markers with survival. IV. To determine physician preference in regard to the radiation-chemotherapy sequence in the Intergroup.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1), chemotherapy/radiotherapy sequence (preoperative vs postoperative), and risk group (high risk \[T3, N+, M0 or T4, any N, M0\] vs low risk \[T1-2, N+, M0 or T3, N0, M0\]). Patients are treated in 1 of 2 groups according to physician preference and then randomized to 1 of 3 treatment arms.

GROUP I (preoperative chemoradiotherapy and additional adjuvant chemotherapy): Preoperative chemoradiotherapy: Patients receive 1 of 3 treatment regimens, determined by the treating physician.

REGIMEN A (radiotherapy and fluorouracil): Patients undergo external beam radiotherapy once daily 5 days a week for 5 1/2 weeks (total of 28 fractions). Patients also receive concurrent fluorouracil intravenously (IV) continuously 7 days a week for 5 1/2 weeks.

REGIMEN B (radiotherapy, fluorouracil, and leucovorin calcium): Patients undergo external beam radiotherapy as in regimen A. Patients also receive concurrent fluorouracil IV and leucovorin calcium IV continuously for 4 days on weeks 1 and 5.

REGIMEN C (radiotherapy and capecitabine)\*: Patients undergo external beam radiotherapy as in regimen A. Patients also receive concurrent oral capecitabine twice daily for 5 1/2 weeks.

NOTE: \*Regimen C is allowed only for patients enrolled on protocol NSABP-R-04.

Surgery: Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection.

Additional adjuvant chemotherapy: Within 21-56 days after complete surgical resection, patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 8 courses.

ARM II: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 8 courses.

ARM III: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 8 weeks for 3 courses.

In all arms, treatment continues in the absence of disease progression or unacceptable toxicity.

GROUP 2 (postoperative chemoradiotherapy and additional adjuvant chemotherapy): Within 21-56 days after complete surgical resection, patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive irinotecan, leucovorin calcium, and fluorouracil as in group 1, arm I for 4 courses.

ARM II: Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in group 1, arm II for 4 courses.

ARM III: Patients receive leucovorin calcium and fluorouracil as in group 1, arm III for 1 course.

Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemoradiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually for 5 years.

Comparison of Adjuvant Chemotherapy Regimens in Treating Stage II/III Rectal Cancer

Intergroup Randomized Phase III Study of Postoperative Irinotecan, 5-Fluorouracil and Leucovorin vs. Oxaliplatin, 5-Fluorouracil and Leucovorin vs. 5-Fluorouracil and Leucovorin for Patients With Stage II or III Rectal Cancer Receiving Either Preoperative Radiation and 5-Fluorouracil or Postoperative Radiation and 5-Fluorouracil

Individual patient data will be shared upon approval

Overall survival (OS) was defined as time from randomization to death from any cause. 3-year OS rate was estimated using Kaplan-Meier method.

Disease free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer and death from any cause, whichever occurred first. 3-year DFS rate was estimated using Kaplan-Meier method.

Proportion of sphincter preservation was defined as number of patients with sphincter preservation divided by total number of patients randomized to the arm

Type of failures (local/regional recurrence vs. distant recurrence vs. concurrent recurrence vs. second primary cancer vs. deaths) in the analysis population

National Cancer Institute (NCI)

Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).

Preoperative chemo/radiation therapy received by Group I patients in step 1

Arm S

Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity.

Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Irinotecan: Given IV

Group I, Arm I

Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 8 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Oxaliplatin: Given IV

Group I, Arm II

Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 8 weeks for 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV

Group I, Arm III

Patients receive irinotecan, leucovorin calcium, and fluorouracil as in group 1, arm I for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Irinotecan: Given IV

Group II, Arm I

Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in group 1, arm II for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Oxaliplatin: Given IV

Group II, Arm II

Patients receive leucovorin calcium and fluorouracil as in group 1, arm III for 1 course. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III. Treatment continues in the absence of disease progression or unacceptable toxicity.

Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV

Group II, Arm III

The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received irinocetan plus 5-FU and leucovorin,

Irinocetan (Arm I)

The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received oxaliplatin plus 5-FU and leucovorin.

Oxaliplatin (Arm II)

The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group only received 5-FU and leucovorin.

Control (Arm III)

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Statistician

The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received irinocetan plus 5-FU and leucovorin.

3-year Overall Survival Rate

The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined.Patients in this group received oxaliplatin plus 5-FU and leucovorin.

3-year Disease Free Survival

Proportion of Sphincter Preservation

Local/regional recurrence only

Distant recurrence only

Both local/regional and distant recurrence

Any recurrence

Second primary cancer

Death

Failure Pattern

Group I patients receive concurrent chemotherapy and radiation prior to surgery.

Group I, Arm S

Patients who had surgery before registering to the study was in Group II. They were registered and randomized at the same time.

Group II, Arm T

Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity.

Radiotherapy: Undergo external beam radiation therapy

Fluorouracil: Given IV

Leucovorin Calcium: Given IV

Irinotecan: Given IV

Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 8 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

Radiotherapy: Undergo external beam radiation therapy

Fluorouracil: Given IV

Leucovorin Calcium: Given IV

Oxaliplatin: Given IV

Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 8 weeks for 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

Radiotherapy: Undergo external beam radiation therapy

Fluorouracil: Given IV

Leucovorin Calcium: Given IV

Patients receive irinotecan, leucovorin calcium, and fluorouracil as in group 1, arm I for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Radiotherapy: Undergo external beam radiation therapy

Fluorouracil: Given IV

Leucovorin Calcium: Given IV

Irinotecan: Given IV

Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in group 1, arm II for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Radiotherapy: Undergo external beam radiation therapy

Fluorouracil: Given IV

Leucovorin Calcium: Given IV

Oxaliplatin: Given IV

Patients receive leucovorin calcium and fluorouracil as in group 1, arm III for 1 course. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III. Treatment continues in the absence of disease progression or unacceptable toxicity.

Radiotherapy: Undergo external beam radiation therapy

Fluorouracil: Given IV

Leucovorin Calcium: Given IV

Step 1: Registration

Step 2: Randomization

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Herbal and Botanical

Capecitabine

Turmeric extract

Curcumin

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Turmeric

Patients undergo radiation therapy 5 days a week for a total of 28 fractions. Patients also receive capecitabine PO BID on the days of radiation therapy and curcumin PO BID in weeks 1-11.5.

Patients undergo radiation therapy and receive capecitabine as in Arm I. Patients also receive placebo PO BID in weeks 1-11.5.

Laboratory Biomarker Analysis

Pharmacological Study

Placebo

Quality-of-Life Assessment

Radiation Therapy

Jillian R. Gunther, PHD

This randomized phase II trial studies how well radiation therapy and capecitabine with or without curcumin before surgery works in treating patients with rectal cancer. Drugs such as curcumin may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether chemotherapy and radiation therapy is more effective with or without curcumin when given before surgery in patients with rectal cancer.

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of a combination of capecitabine and radiation therapy with or without curcumin in locally advanced rectal cancer as assessed by pathological complete response rate.

SECONDARY OBJECTIVES:

I. To determine downstaging, local control, disease-free survival and overall survival rates.

II. To determine serum and rectal tumor tissue pharmacology of curcumin and its metabolites in the above patients and its correlation with clinical response.

III. To identify surrogate molecular markers for curcumin effects. IV. To correlate serum cytokine levels with quality of life in patients receiving this therapy.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo radiation therapy 5 days a week for a total of 28 fractions. Patients also receive capecitabine orally (PO) twice daily (BID) on the days of radiation therapy and curcumin PO BID in weeks 1-11.5.

ARM II: Patients undergo radiation therapy and receive capecitabine as in Arm I. Patients also receive placebo PO BID in weeks 1-11.5.

After completion of study treatment, patients are followed up at 1 month.

Radiation Therapy and Capecitabine With or Without Curcumin Before Surgery in Treating Patients With Rectal Cancer

A Randomized Double Blinded Study of Curcumin With Pre-operative Capecitabine and Radiation Therapy Followed by Surgery for Rectal Cancer

Compared the rate of pCR between treatment arms with Fisher's exact test.

A logistic regression model with pCR as the dependent variable will be used to assess the association between pCR and NF-kB activity and treatment.

Plasma levels were assessed pre and post curcumin/placebo administration. During week 2 (after at least 5 fractions of radiation therapy) of chemoradiation therapy:

1. Optional endoscopic biopsy
2. Optional blood collection for pharmacology (1 hour before and 1 hour after intake of curcumin or placebo)

tumor regression grade (1= pCR, 2= near pCR, 3= partial response, 4= no response, 5=progression).

OS was calculated from start of CRT to date of death, censored at last follow-up. Estimated with the Kaplan-Meier method.

PFS was calculated from start of CRT to date of disease progression or death, censored at last endoscopy/imaging evaluation.

Tumor downstaging (DS) is defined as a decrease in the T stage of the primary tumor by at least 1.

M.D. Anderson Cancer Center

Arm I (Curcumin)

Arm II (Placebo)

Participants received CRT \[50.4 gray in 28 fractions; capecitabine (825 mg/m2 twice daily)\] followed by surgery. Curcumin (4 grams orally, twice daily)

Participants underwent radiation therapy and receive capecitabine as in Arm I. Patients also receive placebo PO BID in weeks 1-11.5.

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues.

Clinical T (Tumor) Stage

Refers to the number and location of lymph nodes that contain cancer. The higher the number after the N, the more lymph nodes that contain cancer.

Clinical N (Nodal) Stage

Tumor Size

Distance from anal verge

Tumor circumference

Pretreatment Carcinoembryonic Antigen (CEA)

Well Differentiated

Moderately Differentiated

Poorly Differentiated

Well differentiated, low grade; Moderately differentiated, intermediate grade; Poorly differentiated, high grade

Number of Participants with Tumor differentiation

Dr. Jillian Gunther

Participants received chemoradiation therapy (CRT) \[50.4 gray in 28 fractions; capecitabine (825 mg/m2 twice daily)\] followed by surgery. Curcumin (4 grams orally, twice daily)

Participants underwent radiation therapy and receive capecitabine as in Arm I. Participants received placebo PO BID in weeks 1-11.5.

Number of Participants With Pathologic Complete Response (pCR) Rate

Participants with analyzable tissue biopsies.

Change in Curcumin Level in Tumor Tissue

Serum curcumin concentrations before curcumin/placebo administration.

Serum curcumin concentrations after curcumin/placebo administration.

Change in Curcumin Level in Serum

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

One patient who did not undergo surgical resection was removed from analyses related to pathologic response outcomes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Adjuvant Chemotherapy Regimens in Treating Stage II/III Rectal Cancer	NCT00068692	Rectal Mucinous... Rectal Signet R... Recurrent Recta... Stage IIA Recta... Stage IIB Recta... Stage IIC Recta... Stage IIIA Rect... Stage IIIB Rect... Stage IIIC Rect... Stage IVA Recta... Stage IVB Recta...	Radiotherapy Fluorouracil Leucovorin Calc... Oxaliplatin Irinotecan	18 Years -	National Cancer Institute (NCI)
Comparison of Adjuvant Chemotherapy Regimens in Treating Stage II/III Rectal Cancer	NCT00068692	Rectal Mucinous... Rectal Signet R... Recurrent Recta... Stage IIA Recta... Stage IIB Recta... Stage IIC Recta... Stage IIIA Rect... Stage IIIB Rect... Stage IIIC Rect... Stage IVA Recta... Stage IVB Recta...	Radiotherapy Fluorouracil Leucovorin Calc... Oxaliplatin Irinotecan	18 Years -	National Cancer Institute (NCI)
Radiation Therapy and Capecitabine With or Without Curcumin Before Surgery in Treating Patients With Rectal Cancer	NCT00745134	Rectal Mucinous... Rectal Signet R... Recurrent Recta... Stage IIA Recta... Stage IIB Recta... Stage IIC Recta... Stage IIIA Rect... Stage IIIB Rect... Stage IIIC Rect...	Capecitabine Curcumin Laboratory Biom... Pharmacological... Placebo Quality-of-Life... Radiation Thera...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for stage iic rectal cancer ajcc v7