Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Melanoma

Sarcoma

Neoplasm Metastasis

Neoplastic Processes

Soft Tissue Sarcoma

RT to site of metastatic disease for three fractions separated by 3 to 8 days. Doses of radiation will increase as follows in order to determine the MTD in Gy:

For all sites the dose levels are as follows:

1. 8 Gy/ fraction x 3 fractions = 24 Gy
2. 10 Gy/fraction x 3 fractions = 30 Gy
3. 12 Gy/fraction x 3 fractions = 36 Gy
4. 14 Gy/fraction x 3 fractions = 42 Gy
5. 16 Gy/fraction x 3 fractions = 48 Gy
6. 18 Gy/fraction x 3 fractions = 52 Gy
7. 20 Gy/fraction x 3 fractions = 60 Gy

Hypofractionated RT

Steven Chmura, MD

Patients with metastatic cancer are generally treated with chemotherapy, which has improved median survival compared to best supportive care. Despite this, patients continue to have persistent disease at sites that were initially involved with cancer. Radiation therapy is an effective modality for treating localized cancer but generally has been only used for palliation of symptoms once a patient develops metastatic disease. Since patients often have persistent disease after chemotherapy, the goal of this trial is to use increasing doses of radiation therapy to all sites of involved disease in order to determine the safety and efficacy of hypofractionated radiation therapy.

The purpose of this study is to establish a maximum tolerated dose, dose-limiting toxicities, and recommended phase 2 dose of hypofractionated radiation therapy.

Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer

A Study of Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer

The dose limiting toxicities occurring within the initial observation period will be defined.

University of Chicago

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Oxaliplatin

Antimetabolites

Hypofractionated radiotherapy + Gemcitabine + Oxaliplatin

Hypofractionated radiotherapy (35 Gy in 7 fractions)

Antonino Romeo, MD

Title: Phase II study of hypofractionated radio-chemotherapy with gemcitabine plus oxaliplatin for unresectable nonmetastatic locally advanced pancreatic cancer.

Protocol code: IRST157.01

Phase: II

Study Design: monocentric, prospective, open-label not randomized trial.

Description of Study Treatment: radio-chemotherapy schedule

* GEMOX: Gemcitabine (GEM) 1000 mg/m2, day 1, and Oxaliplatin (OX) 100 mg/m2, day 2, every 2 weeks for 4 cycles.
* Hypofractionated radiotherapy (35 Gy in 7 fractions in 9 consecutive days, one session per day excluding Saturday and Sunday) administered 15 days after the 4th chemotherapy cycle.
* Further 4 cycles of GEMOX, starting 7-15 days after the end of the radiotherapy.

Objectives:

Step A: primary objective = to evaluate the safety of radiotherapy treatment. Secondary objective = the control of IM (internal margin) intra-fraction.

Step B: primary objective = to evaluate the proportion of the resectable patients after radio-chemotherapy. Secondary objectives = overall Response Rate (ORR); safety profile of combinated treatment;overall survival (OS); local progression free survival (LPFS) and progression free survival (PFS).

Statistical Considerations:

Step A:

Assuming that the probability to observe a toxicity involving the radiotherapy treatment discontinuation with the new treatment is less than 20%, 11 patients are to be evaluated for toxicity. If no toxicity involving the radiotherapy treatment discontinuation will be observed in 11 patients, the treatment can be considered safe with a probability \> 90%. If 1 toxicity involving the radiotherapy treatment discontinuation will be observed, 7 more patients needs to be recruited. If no further toxicity involving the radiotherapy treatment discontinuation occurs, the treatment could be considered safe with a probability ≥ 90%.

If 2 or more toxicity involving the radiotherapy treatment discontinuation on 11 patients or 2 or more toxicity involving the radiotherapy treatment discontinuation on 18 patients will be observed, the study will be stopped because not safe and another kind of radiotherapy schedule must be designed.

Step B:

If the radiotherapy treatment will be considered no toxic, the study will continue in Step B : the goal of this phase II study is to increase the proportion of resectable patients of at least 15% with the new radio-chemotherapeutic treatment. By using the single-stage design (Gehan EA, J Chron Dis 1961) a total of 40 patients is required to be recruited in 2 years, and a further one-year period of follow-up is requested. If at least 7 patients out of 40 enrolled will be resectable, the hypothesis that the proportion of resectable patients will be less or equal to P1 (P1=the proportion of resectable patients with the new radio-chemotherapeutic treatment) will be refused and the treatment could be considered active.

Phase II Study of Hypofractionated Radio-chemotherapy With Gemcitabine Plus Oxaliplatin for Unresectable Nonmetastatic Locally Advanced Pancreatic Cancer.

If no toxicity in 11 patients, the treatment can be considered safe with a probability \> 90%.

If 1 toxicity will be observed, 7 more patients needs to be recruited. If no further toxicity occurs, the treatment could be considered safe with a probability ≥ 90%.

If 2 or more toxicity in 11 patients or 2 or more in18 patients will be observed, the study will be stopped because not safe.

If at least 7 patients out of 40 enrolled will be resectable, the hypothesis that the proportion of resectable patients will be less or equal to P1 (P1=the proportion of resectable patients with the new radio-chemotherapeutic treatment) will be refused and the treatment could be considered active.

It is assessed using RECIST (Response Evaluation Criteria in Solid Tumors) criteria.

It is defined as the proportion of the intention-to-treat (ITT) population showing a complete or partial response, if confirmed ≥ 4 weeks later.

It is counted from the date of registration to the date of death due to any cause or last date the patient was known to be alive (censored observation).

It is counted from the date of registration to the date of the first observation of documentation of objective disease progression/local disease progression or death due to any cause, whichever occurs first.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer	NCT01215500	Tumor Cancer Melanoma Sarcoma Carcinoma	Hypofractionate...	18 Years -	University of Chicago
Phase II Study of Hypofractionated Radio-chemotherapy With Gemcitabine Plus Oxaliplatin for Unresectable Nonmetastatic Locally Advanced Pancreatic Cancer.	NCT02035072	Unresectable Pa... Nonmetastatic P... Locally Advance...	Gemcitabine Oxaliplatin Hypofractionate...	18 Years - 75 Years	Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Spots Global Cancer Trial Database for hypofractionated rt