Recurrent Rectal CancerPANDORANCT01528683
Phase I/II Trial Evaluating Carbon Ion Radiotherapy for the Treatment of Recurrent Rectal Cancer
A study testing Carbon Ion Radiotherapy in people with Recurrent Rectal Cancer, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
Treatment standard for patients with rectal cancer depends on the initial staging and includes surgical resection, radiotherapy as well as chemotherapy. For stage II and III tumors, radiochemotherapy should be performed in addition to surgery, preferentially as preoperative radiochemotherapy or as short-course… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Rectal Cancer
- What is being tested?
- Carbon Ion Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2012to May 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Locally recurrent rectal cancer
- Inoperable lesion
- Macroscopic tumor up to 1000ml volume- prior photon radiation of 20-60 Gy
- time between initial radiotherapy and re-irradiation of at least 12 months
- age ≥ 18 years of age
- Karnofsky Performance Score >60
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- For women with childbearing potential, (and men) adequate contraception.
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent (must be available before enrolment in the trial)
Who cannot join
- refusal of the patients to take part in the study
- advanced metastatic disease
- Patients who have not yet recovered from acute toxicities of prior therapies
- Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy- Pregnant or lactating women
- Participation in another clinical study or observation period of competing trials, respectively.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Heidelberg, Radiation Oncology
Heidelberg
About this study
Treatment standard for patients with rectal cancer depends on the initial staging and includes surgical resection, radiotherapy as well as chemotherapy. For stage II and III tumors, radiochemotherapy should be performed in addition to surgery, preferentially as preoperative radiochemotherapy or as short-course hypofractionated radiation. Advances in surgical approaches, especially the establishment of the total mesorectal excision (TME) in combination with sophisticated radiation and chemotherapy have reduced local recurrence rates to only few percent. However, due to the high incidence of rectal cancer, still a high absolute number of patients present with recurrent rectal carcinomas, and effective treatment is therefore needed.
Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increase relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on the cell line as well as the endpoint analyzed.
Read more
Japanese data on the treatment of patients with recurrent rectal cancer previously not treated with radiation therapy have shown local control rates of carbon ion treatment superior to those of surgery. Therefore, this treatment concept should also be evaluated for recurrences after radiotherapy, when dose application using conventional photons is limited. Moreover, these patients are likely to benefit from the enhanced biological efficacy of carbon ions.
In the current Phase I/II-PANDORA-01-Study the recommended dose of carbon ion radiotherapy for recurrent rectal cancer will be determined in the Phase I part, and feasibility and progression-free survival will be assessed in the Phase II part of the study.
Within the Phase I part, increasing doses from 12 x 3 Gy E to 18 x 3 Gy E will be applied.
The primary endpoint in the Phase I part is toxicity, the primary endpoint in the Phase II part its progression-free survival.
- Conditions
- Recurrent Rectal Cancer
- Being tested
- Carbon Ion Radiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon Ion RadiotherapyRadiation
Treatment with carbon ion radiotherapy using the rasterscanning technique
| Study group | Role | What they receive |
|---|---|---|
| Carbon Ion Radiotherapy | Experimental | Not described Receives: Radiation: Carbon Ion Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Efficacy
Phase I part:
The primary endpoint is toxicity measured by any Grade IV toxicity related to the study treatment according to CTCAE Grade 41. A maximum of 45 patients are projected for the Phase I part of the study. Patients will be followed for at least 3 months after study treatment to document any toxicity according to CTCAE Version 4.0.
Phase II part:
The primary endpoint is progression-free survival after re-irradiation at 12 months, therefore patients are followed within the trial protocol for a minimum 12 months after completion of study treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startDec 2012
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Recurrent Rectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juergen Debus, University Hospital Heidelberg
- Investigators
- Jürgen Debus, MD PhD, Principal investigator, University Hospital of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528683
- Sponsor's protocol ID
- PANDORA
- Acronym
- PANDORA
- Status last verified
- May 2018
- First submitted
- 31 Dec 2011
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Habermehl D, Wagner M, Ellerbrock M, Buchler MW, Jakel O, Debus J, Combs SE. Reirradiation Using Carbon Ions in Patients with Locally Recurrent Rectal Cancer at HIT: First Results. Ann Surg Oncol. 2015;22(6):2068-74. doi: 10.1245/s10434-014-4219-z. Epub 2014 Nov 11.
PubMed 25384705Combs SE, Kieser M, Habermehl D, Weitz J, Jager D, Fossati P, Orrechia R, Engenhart-Cabillic R, Potter R, Dosanjh M, Jakel O, Buchler MW, Debus J. Phase I/II trial evaluating carbon ion radiotherapy for the treatment of recurrent rectal cancer: the PANDORA-01 trial. BMC Cancer. 2012 Apr 3;12:137. doi: 10.1186/1471-2407-12-137.
PubMed 22472035
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial Evaluating Carbon Ion Radiotherapy for the Treatment of Recurrent Rectal Cancer
- ClinicalTrials.gov ID
- NCT01528683
- Acronym / sponsor ID
- PANDORA / PANDORA
- Conditions
- Recurrent Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 8 Feb 2012 (estimated)
- 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.
Treatment standard for patients with rectal cancer depends on the initial staging and includes surgical resection, radiotherapy as well as chemotherapy. For stage II and III tumors, radiochemotherapy should be performed in addition to surgery, preferentially as preoperative radiochemotherapy or as short-course hypofractionated radiation. Advances in surgical approaches, especially the establishment of the total mesorectal excision (TME) in combination with sophisticated radiation and chemotherapy have reduced local recurrence rates to only few percent. However, due to the high incidence of rectal cancer, still a high absolute number of patients present with recurrent rectal carcinomas, and effective treatment is therefore needed.
Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increase relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on the cell line as well as the endpoint analyzed.
Japanese data on the treatment of patients with recurrent rectal cancer previously not treated with radiation therapy have shown local control rates of carbon ion treatment superior to those of surgery. Therefore, this treatment concept should also be evaluated for recurrences after radiotherapy, when dose application using conventional photons is limited. Moreover, these patients are likely to benefit from the enhanced biological efficacy of carbon ions.
In the current Phase I/II-PANDORA-01-Study the recommended dose of carbon ion radiotherapy for recurrent rectal cancer will be determined in the Phase I part, and feasibility and progression-free survival will be assessed in the Phase II part of the study.
Within the Phase I part, increasing doses from 12 x 3 Gy E to 18 x 3 Gy E will be applied.
The primary endpoint in the Phase I part is toxicity, the primary endpoint in the Phase II part its progression-free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carbon Ion Radiotherapy | Experimental | Radiation: Carbon Ion Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Locally recurrent rectal cancer
- Inoperable lesion
- Macroscopic tumor up to 1000ml volume- prior photon radiation of 20-60 Gy
- time between initial radiotherapy and re-irradiation of at least 12 months
- age ≥ 18 years of age
Key exclusion criteria (5 listed)
- refusal of the patients to take part in the study
- advanced metastatic disease
- Patients who have not yet recovered from acute toxicities of prior therapies
- Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy- Pregnant or lactating women
- Participation in another clinical study or observation period of competing trials, respectively.
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 |
|---|---|---|
| Carbon Ion RadiotherapyTreatment with carbon ion radiotherapy using the rasterscanning technique | Radiation | Carbon Ion Radiotherapy |
Primary outcome
Safety and Efficacy
Time frame: 3 months
Phase I part: The primary endpoint is toxicity measured by any Grade IV toxicity related to the study treatment according to CTCAE Grade 41. A maximum of 45 patients are projected for the Phase I part of the study. Patients will be followed for at least 3 months after study treatment to document any toxicity according to CTCAE Version 4.0. Phase II part: The primary endpoint is progression-free survival after re-irradiation at 12 months, therefore patients are followed within the trial protocol for a minimum 12 months after completion of study treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Derived from this study: PubMed 25384705Habermehl D, Wagner M, Ellerbrock M, Buchler MW, Jakel O, Debus J, Combs SE. Reirradiation Using Carbon Ions in Patients with Locally Recurrent Rectal Cancer at HIT: First Results. Ann Surg Oncol. 2015;22(6):2068-74. doi: 10.1245/s10434-014-4219-z. Epub 2014 Nov 11.
- Derived from this study: PubMed 22472035Combs SE, Kieser M, Habermehl D, Weitz J, Jager D, Fossati P, Orrechia R, Engenhart-Cabillic R, Potter R, Dosanjh M, Jakel O, Buchler MW, Debus J. Phase I/II trial evaluating carbon ion radiotherapy for the treatment of recurrent rectal cancer: the PANDORA-01 trial. BMC Cancer. 2012 Apr 3;12:137. doi: 10.1186/1471-2407-12-137.
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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.
Jürgen Debus, MD PhD principal investigator
University Hospital of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon Ion Radiotherapy in people with Recurrent Rectal Cancer, run by University Hospital Heidelberg at 1 site in Germany.
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 9 inclusion and 5 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: finished, as of the sponsor's last update on 17 May 2018. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Efficacy (time frame: 3 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 NCT01528683, which also lists 2 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 17 May 2018.