Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam and Capecitabine for Resectable Pancreatic Cancer

NCT00438256 | Completed Phase 1 Results DMC

• 1 other identifier: 06-248
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

A standard treatment for pancreatic cancer is radiation therapy plus chemotherapy after surgery. Radiation therapy and chemotherapy are commonly given for up to six weeks. Previous research has suggested that giving the radiation and chemotherapy for a shorter amount of time (accelerated schedule) before surgery may be better tolerated. In this research study, different schedules of proton radiation therapy will be used. Each schedule will give about the same total dose of radiation. However, the total dose will be spread out over different time periods and different numbers of sessions. The purpose is to find the shortest schedule of radiation therapy that can be given without unacceptable side effects. Proton beam radiation is being used because of its unique ability to deposit its energy directly in the tumor, resulting in less radiation to normal tissue. A new type of PET scan is also being studied to see if it can help predict the response to pre-surgery treatment.

Conditions

Pancreatic Cancer

Keywords

accelerated short course; proton beam radiation

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Dose Limiting Toxicities in the 5 Radiation Sessions in One Week Arm

  The number of participants that experienced a dose limiting toxicity in the arm where radiation was administered over 5 consecutive for a total dose of 25 Gray Equivalents (GyE) (Group 4). Participants were monitored for potential Dose Limiting Toxicities (DLT) for three weeks after the start of radiation. DLTs included: 1. Any grade 3 non-hematologic or hematologic toxicity requiring a greater than 7 day interruption in therapy (excluding alopecia and nausea/vomiting not controlled by optimal supportive care or 2. Any grade 4 non-hematologic toxicity or 3. Any grade 4 neutropenia or thrombocytopenia as defined by Common Terminology Criteria for Adverse Events (CTCAE v3.0)

  3 Weeks

• Number of Participants With Grade 3 or Greater Toxicity in Phase II

  Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3). The regimen was considered to be tolerated if less than 20% of participants experienced a grade 3 or greater toxicity.

  30 days after the end of treatment, up to approximately 6 months total

Secondary Outcomes (5)

• Number of Participants With a Pathological Complete Response

  at the time of surgery (28-42 days after start of treatment)

• Median Progression Free Survival

  from the start of treatment until death or progression, median duration of 10.4 months

• Number of Participants With Surgical Morbidity

  30 days post surgery (surgery was 28-42 days after the start of treatment)

• 30-Day Post Operative Mortality

  30 days after the time of surgery (Surgery is 28-42 days after start of treatment)

• Number of Participants With Treatment Related Serious Adverse Events

  From the start of treatment until 30 days after the end of treatment, up to approximately 5 months

Study Arms (4)

Group 1

EXPERIMENTAL

10 Radiation Sessions over 2 weeks

Procedure: Proton Beam Radiation; Drug: Capecitabine

Group 2

EXPERIMENTAL

5 Radiation sessions: 3 in week 1 and 2 in week 2

Procedure: Proton Beam Radiation; Drug: Capecitabine

Group 3

EXPERIMENTAL

5 Radiation sessions: 4 in week 1 and 1 in week 2

Procedure: Proton Beam Radiation; Drug: Capecitabine

Group 4

EXPERIMENTAL

5 Radiation Sessions in one week

Procedure: Proton Beam Radiation; Drug: Capecitabine

Interventions

Proton Beam Radiation PROCEDURE

Given over different schedules and duration

Group 1; Group 2; Group 3; Group 4

Capecitabine DRUG

Given orally starting on day one of radiation therapy for 2 weeks

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cytologic of histologic proof of pancreatic ductal carcinoma
• No evidence of metastatic disease
• years of age or older
• ECOG Performance Status of 0 or 1 - Lab values as outlined in the protocol

You may not qualify if:

• Tumors in the body or tail of the pancreas
• Hepatic or peritoneal metastases detected by imaging or laparoscopy prior to chemoradiation
• Serious concomitant systemic disorders incompatible with the study, such as significant cardiac or pulmonary morbidity, ongoing infection as manifested by fever
• Pregnant or lactating women
• Life expectancy of \< 3 months
• Serious, uncontrolled, concurrent infection (s)
• Prior chemotherapy or radiation for treatment of the patient's pancreatic tumor
• Clinically significant cardiac disease or myocardial infarction within the last 12 months
• Other serious uncontrolled medical condition that the investigator feels might compromise study participation
• Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
• Known, existing uncontrolled coagulopathy
• Any prior fluoropyrimidine therapy
• Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to a 5-fluorouracil or known DPD deficiency
• Participation in any investigational drug study within 4 weeks preceding the start of the study
• History of uncontrolled seizures, central nervous system disorders or psychiatric disability

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Hong TS, Ryan DP, Borger DR, Blaszkowsky LS, Yeap BY, Ancukiewicz M, Deshpande V, Shinagare S, Wo JY, Boucher Y, Wadlow RC, Kwak EL, Allen JN, Clark JW, Zhu AX, Ferrone CR, Mamon HJ, Adams J, Winrich B, Grillo T, Jain RK, DeLaney TF, Fernandez-del Castillo C, Duda DG. A phase 1/2 and biomarker study of preoperative short course chemoradiation with proton beam therapy and capecitabine followed by early surgery for resectable pancreatic ductal adenocarcinoma. Int J Radiat Oncol Biol Phys. 2014 Jul 15;89(4):830-8. doi: 10.1016/j.ijrobp.2014.03.034. Epub 2014 May 24.

  PMID: 24867540 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Proton Therapy; Capecitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Theodore Hong, MD
• Organization: Massachusetts General Hospital

TSHONG1@mgh.harvard.edu

617-724-1159

Study Officials

• Theodore Hong, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Radiation Oncologist

Study Record Dates

• First Submitted: February 20, 2007
• First Posted: February 22, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 23, 2019
• Results First Posted: January 23, 2019

Record last verified: 2018-12

Locations

US (2)