Adjuvant Chemoradiation Following Radical Resection of Pancreatic Ductal Adenocarcinoma, a Prospective Cohort Study

Surgery Clinical Trial

Official title:

Adjuvant Chemoradiation Following Radical Resection of Pancreatic Ductal Adenocarcinoma, a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04737551
• Other study ID #: A-RPC
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2021
• Source: Shanghai Zhongshan Hospital
• Contact: Yaolin Xu, M.D.
• Phone: +86-18817583729
• Email: xu.yaolin[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a prospective observation cohort study to evaluate efficacy of different types of adjuvant therapy strategies, including chemoradiotherapy, chemotherapy alone, or no adjuvant treatment, for pancreatic ductal adenocarcinoma patients who received surgical resection of primary cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age between 18 to 90 years.

2. Received surgical resection of primary tumor.

3. Histological diagnosis of pancreatic ductal adenocarcinoma.

4. Signed informed consent.

Exclusion Criteria:

1.Active concomitant malignancy (Malignancy other than pancreatic cancer).

Related Conditions & MeSH terms

• Adenocarcinoma
• Adjuvant Chemoradiotherapy
• Resectable Pancreatic Cancer
• Surgery

Intervention

Other:
• Follow-up only
Only routine follow-up but no treatment

Drug:
• Adjuvant chemotherapy
Chemotherapy regimens will be decided by physicians or MDT teams, basing on patients' physical status, income status, and/or desire. Toxicity was evaluated every cycle and efficacy was evaluated every two cycles. The treatment course of adjuvant chemotherapy was followed the recommendation of NCCN guideline.

Radiation:
• Adjuvant chemoradiotherapy
Adjuvant CRT could be delivered before or simultaneously with adjuvant chemotherapy. Radiation used 6 MV or 15 MVX-ray beams delivering daily fractions of 180-200cGy to a total dose of 45-55Gy in 25-28 fractions using CT-based, three-dimensional conformal radiation therapy (3DRT), intensity-modulated radiation therapy (IMRT) or tomotherapy (TOMO). S-1 was administered orally at a dose of 40mg twice a day during radiation day as radiosensitizer through radiotherapy. Antiemetic medications and proton pump inhibitor were prophylactic used to reduce the occurrence of nausea and inhibit gastric acid secretion.
• Adjuvant chemoradiotherapy + Adjuvant chemotherapy
See as above (adjuvant chemotherapy and adjuvant chemoradiotherapy).

Locations

Country	Name	City	State
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Abrams MJ, Huber KE, Knisely JP, Chang BW, Russo SM, Saif MW. Capecitabine as a Radiosensitizer in Adjuvant Chemoradiotherapy for Pancreatic Cancer: A Retrospective Study. Anticancer Res. 2015 Dec;35(12):6901-7. — View Citation

Goodman KA, Regine WF, Dawson LA, Ben-Josef E, Haustermans K, Bosch WR, Turian J, Abrams RA. Radiation Therapy Oncology Group consensus panel guidelines for the delineation of the clinical target volume in the postoperative treatment of pancreatic head cancer. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):901-8. doi: 10.1016/j.ijrobp.2012.01.022. Epub 2012 Apr 5. — View Citation

Ma SJ, Hermann GM, Prezzano KM, Serra LM, Iovoli AJ, Singh AK. Adjuvant chemotherapy followed by concurrent chemoradiation is associated with improved survival for resected stage I-II pancreatic cancer. Cancer Med. 2019 Mar;8(3):939-952. doi: 10.1002/cam4.1967. Epub 2019 Jan 16. — View Citation

Palta M, Godfrey D, Goodman KA, Hoffe S, Dawson LA, Dessert D, Hall WA, Herman JM, Khorana AA, Merchant N, Parekh A, Patton C, Pepek JM, Salama JK, Tuli R, Koong AC. Radiation Therapy for Pancreatic Cancer: Executive Summary of an ASTRO Clinical Practice Guideline. Pract Radiat Oncol. 2019 Sep - Oct;9(5):322-332. doi: 10.1016/j.prro.2019.06.016. — View Citation

Uesaka K, Boku N, Fukutomi A, Okamura Y, Konishi M, Matsumoto I, Kaneoka Y, Shimizu Y, Nakamori S, Sakamoto H, Morinaga S, Kainuma O, Imai K, Sata N, Hishinuma S, Ojima H, Yamaguchi R, Hirano S, Sudo T, Ohashi Y; JASPAC 01 Study Group. Adjuvant chemotherapy of S-1 versus gemcitabine for resected pancreatic cancer: a phase 3, open-label, randomised, non-inferiority trial (JASPAC 01). Lancet. 2016 Jul 16;388(10041):248-57. doi: 10.1016/S0140-6736(16)30583-9. Epub 2016 Jun 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Experiencing Adverse Events	Number of participants experiencing adverse events during chemoradiation and during adjuvant chemotherapy, at any grade, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. This is used to determine the Toxicity profile.	Up to 60 months
Primary	Overall Survival	Overall survival (OS) was defined as the time interval from the date of surgery to the date of death due to any cause or the date a patient was last known to be alive. Estimated by using the Kaplan-Meier method.	Up to 60 months
Secondary	Disease Free Survival	Disease free survival (DFS) was defined as the time interval from the date of surgery to the date of disease recurrence or death or the date of a participant was last known to be alive without disease recurrence. Response was evaluated according to revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	Up to 48 months