Resectable Pancreatic CancerNCT04737551
Adjuvant Chemoradiation Following Radical Resection of Pancreatic Ductal Adenocarcinoma, a Prospective Cohort Study
An observational study of Resectable Pancreatic Cancer and Adjuvant Chemoradiotherapy, run by Shanghai Zhongshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Resectable Pancreatic Cancer, Adjuvant Chemoradiotherapy, Surgery
- What is being tested?
- Follow-up only, Adjuvant chemotherapy and Adjuvant chemoradiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2023
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elegible patients were those who received surgical resection of primary pancreatic tumor and were histologically diagonsed as pancreatic ductal adenocarcinoma.
Who may be able to join
- Age between 18 to 90 years.
- Received surgical resection of primary tumor.
- Histological diagnosis of pancreatic ductal adenocarcinoma.
- Signed informed consent.
Who cannot join
- 1.Active concomitant malignancy (Malignancy other than pancreatic cancer).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Xiangyu Wang, M.D., 86-021-31587871, keyanke@zs-hospital.sh.cn
Wenhui Lou, M.D., Ph.D
About this study
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.
- Being tested
- Follow-up only, Adjuvant chemotherapy, Adjuvant chemoradiotherapy, Adjuvant chemoradiotherapy + Adjuvant chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up onlyOther
Only routine follow-up but no treatment
Adjuvant chemotherapyDrug
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.
Adjuvant chemoradiotherapyRadiation
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 chemotherapyRadiation
See as above (adjuvant chemotherapy and adjuvant chemoradiotherapy).
| Study group | Role | What they receive |
|---|---|---|
| No adjuvant treatment | Pancreatic cancer patients who received surgery without subsequent adjuvant treatment. Receives: Other: Follow-up only | |
| Adjuvant chemotherapy | Pancreatic cancer patients who received surgery and only adjuvant chemotherapy. Receives: Drug: Adjuvant chemotherapy | |
| Adjuvant chemoradiotherapy | Pancreatic cancer patients who received surgery and only adjuvant chemoradiotherapy. Receives: Radiation: Adjuvant chemoradiotherapy | |
| Adjuvant chemoradiotherapy + adjuvant chemotherapy | Pancreatic cancer patients who received surgery and both adjuvant chemoradiotherapy and chemotherapy. Receives: Radiation: Adjuvant chemoradiotherapy + Adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 60 months
Secondary outcomes (1)
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.
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Resectable Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737551
- Sponsor's protocol ID
- A-RPC
- Status last verified
- Feb 2021
- First submitted
- 25 Jan 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27265347Goodman 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.
PubMed 22483737Palta 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.
PubMed 31474330Ma 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.
PubMed 30652417Abrams 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.
PubMed 26637914
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Chemoradiation Following Radical Resection of Pancreatic Ductal Adenocarcinoma, a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04737551
- Acronym / sponsor ID
- A-RPC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No adjuvant treatment | – | Other: Follow-up onlyPancreatic cancer patients who received surgery without subsequent adjuvant treatment. |
| Adjuvant chemotherapy | – | Drug: Adjuvant chemotherapyPancreatic cancer patients who received surgery and only adjuvant chemotherapy. |
| Adjuvant chemoradiotherapy | – | Radiation: Adjuvant chemoradiotherapyPancreatic cancer patients who received surgery and only adjuvant chemoradiotherapy. |
| Adjuvant chemoradiotherapy + adjuvant chemotherapy | – | Radiation: Adjuvant chemoradiotherapy + Adjuvant chemotherapyPancreatic cancer patients who received surgery and both adjuvant chemoradiotherapy and chemotherapy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elegible patients were those who received surgical resection of primary pancreatic tumor and were histologically diagonsed as pancreatic ductal adenocarcinoma.
Key inclusion criteria (4 listed)
- Age between 18 to 90 years.
- Received surgical resection of primary tumor.
- Histological diagnosis of pancreatic ductal adenocarcinoma.
- Signed informed consent.
Key exclusion criteria (1 listed)
- 1.Active concomitant malignancy (Malignancy other than pancreatic cancer).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow-up onlyOnly routine follow-up but no treatment | Other | No adjuvant treatment |
| Adjuvant chemotherapyChemotherapy 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. | Drug | Adjuvant chemotherapy |
| Adjuvant chemoradiotherapyAdjuvant 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. | Radiation | Adjuvant chemoradiotherapy |
| Adjuvant chemoradiotherapy + Adjuvant chemotherapySee as above (adjuvant chemotherapy and adjuvant chemoradiotherapy). | Radiation | Adjuvant chemoradiotherapy + adjuvant chemotherapy |
Primary outcome
Overall Survival
Time frame: Up to 60 months
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.
1 secondary outcome
Disease Free Survival
Time frame: Up to 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Background: PubMed 27265347Uesaka 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.
- Background: PubMed 22483737Goodman 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.
- Background: PubMed 31474330Palta 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.
- Background: PubMed 30652417Ma 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.
- Background: PubMed 26637914Abrams 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resectable Pancreatic Cancer and Adjuvant Chemoradiotherapy, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaolin Xu, M.D. (+86-18817583729, xu.yaolin@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04737551, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.