Neoplasms

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Digestive System Diseases

Adenocarcinoma

Rectal Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Colorectal Neoplasms

Intestinal Neoplasms

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Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

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Capecitabine

Leucovorin

Fluorouracil

Levoleucovorin

Oxaliplatin

Folinic Acid

* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).

  * Oxaliplatin day 1 every 14 days
  * Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
  * 5-FU bolus day 1 every 14 days
  * 5-FU infusion day 1 every 14 days over 46 hours
* Alternatively CAPOX (capecitabine and oxaliplatin) may be given for 5 cycles over 15 weeks.
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted

-Monday-Friday treatment is strongly recommended

Radiation therapy

FOLFOX regimen

-Baseline, completion of chemotherapy (3-8 weeks after the end of chemotherapy), and 10 to 14 months after radiotherapy

Functional Assessment of Cancer Therapy-Colorectal cancer (FACT-C) questionnaire

-Multiple biopsy samples of the rectal tumor will be taken from the patient tumor prior to treatment initiation for genomic extraction. For patients at affiliate sites who do not have enough tissue from the diagnostic biopsy, a repeat pre-treatment biopsy is optional.

Rectal biopsy samples

-Prior to the start of treatment, Post radiation therapy labs (with standard of care (SOC) CBC/CMP prior to start of cycle 1 of chemotherapy), Day 1 of cycle 2 of chemotherapy (with SOC CBC/CMP), Completion of chemotherapy (3-8 weeks after the end of chemotherapy), 10-14 months after RT (if this visit aligns with a follow-up time point, one draw can be used to satisfy both time points), months 3, 6, 9, 12, 16, 20, 24 until salvage surgery or 2 years from completion of chemotherapy (whichever is first)

Blood for ctDNA

Hyun Kim, M.D.

The investigators' data from a phase I study of short course radiation therapy followed by chemotherapy showed 74% complete clinical response (cCR). Given the promising response rate, the investigators are evaluating short course radiation therapy (SCRT) followed by chemotherapy in a multi-institution phase II trial to validate the cCR rate of this treatment paradigm. SCRT has not been prospectively evaluated in non-operative management for patients with non-metastatic rectal adenocarcinoma.

Non-Operative Management and Early Response Assessment in Rectal Cancer

Deidentified data will be shared with investigators who submit a sound proposal. Participants who opted out of data sharing in the informed consent will not be included.

-Criteria for clinical complete response:

* No residual gross tumor at procto/sigmoidoscopy;, or only erythematous scar or ulcer
* No palpable tumor on DRE
* No radiographic evidence of tumor on MRI
* No suspicious mesorectal lymph nodes on MRI
* Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment)

* Criteria for progressive disease:

  * Increase in the size of primary tumor by RECIST criteria (increase of at least 20% from nadir in the sum of the target lesion, with an absolute increase of at least 5 mm)
  * New metastatic disease
* PFS is defined as the time from date of treatment to death or progression, which occurs first. The alive patients without progression are censored as the last date follow-up.

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

* Questionnaire with 5 sections (physical well-being, social/family well being, emotional well-being, functional well-being, and additional concerns)
* Answers to the questions range from 0=not at all to 4=very much. The higher the total score the lower quality of life

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Non-Operative Management and Early Response Assessment in Rectal Cancer	NCT03904043	Adenocarcinoma ...	Radiation thera... FOLFOX regimen Functional Asse... Rectal biopsy s... Blood for ctDNA	18 Years -	Washington University School of Medicine
Non-Operative Management and Early Response Assessment in Rectal Cancer	NCT03904043	Adenocarcinoma ...	Radiation thera... FOLFOX regimen Functional Asse... Rectal biopsy s... Blood for ctDNA	18 Years -	Washington University School of Medicine

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